FDA: Page 20
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Speedy FDA approvals in focus as agency weighs withdrawal of preterm birth drug
The FDA will soon decide whether to pull Covis’ Makena from the market, more than three years after its confirmatory study failed. The delay highlights the need for reforms to the accelerated approval program, critics say.
By Jonathan Gardner , Christopher Newman • Oct. 21, 2022 -
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FDA advisers back withdrawal of controversial drug for preterm birth
A committee of independent experts voted 14-1 that the agency shouldn’t allow the treatment from Covis Pharma to remain on the market while further testing is conducted.
By Jonathan Gardner • Updated Oct. 19, 2022 -
Sarah Silbiger via Getty Images
FDA opens case to withdraw controversial drug for preterm births
Beginning a high-stakes advisory meeting, CDER head Patrizia Cavazzoni said that Covis Pharma’s drug is ineffective and should not remain on the market.
By Ned Pagliarulo • Oct. 17, 2022 -
Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
‘We have to find a way’: FDA seeks solutions to aid bespoke gene therapy
Gene therapies could help treat many ultra-rare diseases. But they may not get developed if drugmakers can’t build a sustainable business around them, CBER director Peter Marks said at a conference.
By Ned Pagliarulo • Oct. 13, 2022 -
Sarah Silbiger via Getty Images
Omicron boosters from Pfizer, Moderna cleared by FDA for younger children
Pfizer's reformulated vaccine is now authorized for use in children at least 5 years of age, while Moderna's will be available for kids as young as 6.
By Ned Pagliarulo • Oct. 12, 2022 -
Sarah Silbiger via Getty Images
FDA rejects Supernus’ drug infusion device for Parkinson’s
The company said it will work with the FDA to address issues flagged by the agency in a complete response letter for the apomorphine infusion device.
By Delilah Alvarado • Oct. 10, 2022 -
Courtesy of Eli Lilly
Lilly looks to speed FDA review of new diabetes drug in obesity
A new fast track designation allows Lilly to begin the process of seeking approval of tirzepatide for obesity, though the drug will need to succeed in a second trial to get to market.
By Jonathan Gardner • Oct. 6, 2022 -
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FDA clears Roche test for AstraZeneca, Daiichi’s breast cancer drug
The diagnostic will support rollout of Enhertu, which recently became the first drug for breast tumors with low, but still detectable, levels of the protein HER2.
By Nick Paul Taylor • Oct. 5, 2022 -
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5 FDA decisions to watch in the fourth quarter
The regulator could soon approve medicines from Apellis, Gilead and GSK, and decide whether to pull a controversial preterm birth drug from the market.
By Ben Fidler , Ned Pagliarulo , Delilah Alvarado , Jacob Bell , Jonathan Gardner • Oct. 3, 2022 -
Alex Wong via Getty Images
Federal watchdog highlights flaws in speedy FDA approvals
A newly published report by the HHS inspector general found that a substantial number of drugs given an accelerated approval by the FDA still haven’t proven whether they help patients.
By Jonathan Gardner • Sept. 30, 2022 -
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BioMarin resubmits its hemophilia gene therapy to the FDA
The resubmission has been long awaited after BioMarin’s original application was unexpectedly rejected by the FDA two years ago. The company expects a decision around the middle of next year.
By Delilah Alvarado • Sept. 30, 2022 -
Anne Callahan/BioPharma Dive
Sponsored by TD2 Precision Oncology[PODCAST] Evolution and Innovation in Oncology Therapeutics Development
The “Evolution and Innovation in Oncology Therapeutics Development” podcast series explores the role of multi-biomarkers in precision oncology.
By BioPharma Dive's studioID • Updated Sept. 11, 2023 -
Permission granted by Amylyx Pharmaceuticals
ALS drug developmentALS drug approved by FDA in closely watched decision, marking win for patients, developer
The drug, which will be sold as Relyvrio, showed modest benefits in function and survival in testing. It also became the latest test of the FDA's flexibility toward new therapies for neurological disorders.
By Jacob Bell • Updated Sept. 30, 2022 -
Courtesy of Pfizer
Pfizer, BioNTech seek FDA clearance for updated COVID-19 booster in children
The request, if cleared, would make U.S. kids between 5 through 11 eligible to receive a "bivalent" shot targeting components of the omicron variants currently circulating.
By Delilah Alvarado • Sept. 26, 2022 -
Joe Raedle / Getty via Getty Images
FDA user fee package to be included in bill to fund government, avoid shutdown, senators say
A “practically clean” version of the bill will allow the FDA to continue its review and testing programs, while leaving more ambitious goals to be dealt with in a funding bill later this year.
By Elise Reuter • Sept. 23, 2022 -
Sarah Silbiger via Getty Images
FDA advisers back microbiota-based treatment for gut infection
Committee members voted in support of Rebiotix’s treatment for recurrent C. diff infections of the intestines, a condition with no approved options after antibiotics fail.
By Christopher Newman • Updated Sept. 23, 2022 -
Courtesy of Eli Lilly
Lilly drug wins FDA clearance for gene-mutated solid tumors, regardless of type
The approval is another example of so-called tissue-agnostic indications, which are based on a cancer’s genetic signature rather than where it is in the body.
By Kristin Jensen • Sept. 22, 2022 -
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Fennec wins approval of first drug for chemotherapy-induced hearing loss in children
The drug, Pedmark, has been in development for more than two decades and was previously rejected twice by U.S. regulators.
By Christopher Newman • Sept. 21, 2022 -
Courtesy of Bluebird bio
Bluebird wins FDA approval of gene therapy for rare brain disorder
The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million per patient.
By Ned Pagliarulo • Updated Sept. 17, 2022 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
FDA, NIH initiative aims to speed development of drugs for ALS, other brain diseases
The public-private partnership plans to bring together scientific experts, private entities and patient groups to better understand certain neurodegenerative disorders and find new treatments.
By Kristin Jensen • Sept. 15, 2022 -
Danielle Ternes/BioPharma Dive
BioMarin reports cancer case in hemophilia gene therapy trial
The development comes three weeks after Roctavian was approved in Europe and ahead of a planned regulatory submission in the U.S. Drug regulators have not ordered a trial hold, however.
By Jonathan Gardner • Sept. 13, 2022 -
Permission granted by Bristol-Myers Squibb
Bristol Myers gets FDA approval for new type of psoriasis drug
Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company.
By Jonathan Gardner • Updated Sept. 12, 2022 -
Sarah Silbiger via Getty Images
ALS drug developmentHow a top FDA official’s words helped push a closely watched ALS drug toward approval
Comments by Billy Dunn, head of the FDA’s neuroscience office, played a major role in a vote by an advisory panel Wednesday in support of the medicine, which is in the final stages of regulatory review.
By Ned Pagliarulo • Sept. 9, 2022 -
Sarah Silbiger via Getty Images
FDA names new head to vaccine review office
David Kaslow, the lead scientist at a global public health nonprofit, will succeed Marion Gruber, who retired last fall amid her dissent on the timing of COVID-19 vaccine boosters.
By Jonathan Gardner • Sept. 9, 2022 -
Sarah Silbiger via Getty Images
FDA advisers back Amylyx ALS drug, reversing earlier position
Committee members voted 7-2 in support of the experimental medicine, which is under a closely watched FDA review. A decision on approval is expected by the end of the month.
By Jacob Bell • Updated Sept. 7, 2022
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